BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD

    MDR report key: 1241088 · Received November 21, 2008

    Report

    Report Number
    2024168-2008-01204
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE COILS. THERE WAS CORROSION PRESENT ON THE PROXIMAL SOLDER. THE TIP COILS WERE STRETCHED DISTAL TO THE CENTER SOLDER FOR A LENGTH OF 2.1 CM AND THEN DETACHED. THE SEPARATED TIP COILS WERE UNRAVELED FOR A LENGTH OF 34 CM. THE SHAPING RIBBON WAS DETACHED 2.4 CM DISTAL TO THE CENTER SOLDER. THE SHAPING RIBBON WAS CORKSCREWED ON BOTH ENDS. THE SEPARATED SHAPING RIBBON AND TIP COILS WERE STILL ATTACHED TO THE TIPBALL. THE CORE WAS STILL INTACT. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THIS WILL BE SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME FOR THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: SEPARATE GUIDE WIRE REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: SEPARATED GUIDE WIRE. IT WAS REPORTED THAT A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE PASSED THE LESION, AND THEN A BALLOON WAS PASSED INTO THE LESION FOR PREDILATATION, BUT IT WOULD NOT GO THROUGH. AT THIS POINT, THE TIP OF THE GUIDE WIRE SEPARATED IN THE CORONARY, BUT WAS SUCCESSFULLY RETRIEVED WITH ANOTHER COMPANY'S STENT DELIVERY SYSTEM. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8080881

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention